These new regulations represent a significant step in aligning Ukraine\u2019s medical device framework with the following EU legislation: Regulation 2017\/745 on medical devices (MDR<\/strong>) and Regulation 2017\/746 on in vitro diagnostic medical devices (IVDR<\/strong>).<\/p>\n The new regulations will gradually replace the existing 2013 Technical Regulations on:<\/p>\n Key changes under the new framework<\/strong><\/p>\n The new framework introduces updated conformity assessment procedures, revised risk classification rules, enhanced post-market surveillance requirements and strengthened product traceability measures. These include the introduction of a Unique Device Identification (UDI<\/strong>) system and Single Registration Numbers (SRN<\/strong>s) for economic operators. By December 2029, Ukraine also plans to establish a National Medical Devices Database compatible with the European database on medical devices (EUDAMED<\/strong>).<\/p>\n New regulatory and market surveillance authority \u2013 Ukrainian Pharmaceutical Agency<\/strong><\/p>\n The Ukrainian Pharmaceutical Agency is expected to become operational on 1 January 2027, and will take over responsibility for medical devices from the State Service of Ukraine on Medicines and Drugs Control.<\/p>\n Recognition of EU conformity assessments remains possible<\/strong><\/p>\n The new regulations do not affect the existing mechanism for recognising conformity assessment results obtained in the EU. As a result, conformity certificates, quality management system audits and other conformity assessment outcomes issued in the EU may continue to be recognised in Ukraine under the current recognition framework.<\/p>\n Implementation timeline and transitional provisions<\/strong><\/p>\n The Resolutions go into force in mid-December 2026, although the substantive requirements of the New Regulations and the repeal of the current 2013 Technical Regulations, will generally apply from 31 December 2030. To support a smooth transition, the New Regulations provide for relevantly lengthy transitional periods.<\/p>\n General transitional period<\/strong><\/p>\n Medical devices and IVDs placed on the market by 30 December 2030<\/strong> (inclusive) under the current technical regulations may continue to be made available on the market or put into service after that date without restrictions.<\/p>\n Conformity documents issued by notified bodies under the current technical regulations, and valid as of 31 December 2030<\/strong>, will remain valid until their expiry date but not later than 31 December 2031<\/strong>.<\/p>\n Extended transitional period of one year<\/strong><\/p>\n Until 31 December 2031, certain devices may continue to be placed on the market or put into service if:<\/p>\n Devices that will require notified body involvement<\/strong><\/p>\n For medical devices, this includes:<\/p>\n For IVDs, this applies to:<\/p>\n What should medtech companies do now?<\/strong><\/p>\n Although the new regulations will only become applicable at the end of 2030, manufacturers, authorised representatives, importers and distributors should begin assessing their readiness for the new framework and its potential impact on their product portfolios. In particular, the transitional provisions effectively create a relatively short 12-month window to obtain new conformity documentation under the new framework.<\/p>\n Medtech companies should do the following:<\/p>\n For more information on Ukraine\u2019s new regulations on medical devices and in vitro devices, contact<\/p>\n On 10 June 2026, the Cabinet of Ministers of Ukraine (CMU) adopted new technical regulations on medical devices: Resolution No. 759 \u2013 the Technical Regulation on Medical Devices; Resolution No. 758 \u2013 the Technical Regulation on In Vitro Diagnostic Medical Devices. These new regulations represent a significant step in aligning Ukraine\u2019s medical device framework with […]<\/p>\n","protected":false},"author":4489,"featured_media":759699,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[24,23],"tags":[],"yoast_head":"\n\n
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